Women's Health Center

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for evaluation of proficiency testing performance from CMS, laboratory proficiency reporting from API, and an interview with the laboratory personnel (LP) on 11/2/2021 between 8:30 a.m. and 10:30 a.m., it was determined that there was one cycle of unacceptable proficiency testing (PT) results for Microbiology for cycle 3 in 2019. Findings include: 1. On 11/2/2021, an inspection was conducted between 8:30 a.m. and 10:30 am. 2 During a review of the laboratory documentation from API (agency providing the proficiency specimens), it was noted at approximately 9 a.m. that there were three unacceptable PT results for cycle 3 in 2019. The LP recognized these atypical results. 3. The findings were as follows: Microbiology Bacteriology: Garderella Vaginalis Result: 0 % Microbiology Mycology (Candida sp.) Result: 0 % Microbiology Parasitology (Trichomonas vag.) Result: 0 % 4. The LP affirmed the unacceptable results listed above. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on the surveyor's review of the laboratory's records for evaluation of competency reporting and an interview with laboratory personnel (LP) on 11/2/2021 between 8:30 a.m and 10:30 a.m. , it was determined that the staff competency reports for one medical assistant (MA) were missing for 2020. Findings include: 1. On 11/2 //2021, an inspection was conducted between 8:30 a.m. and 10:30 a.m. 2. During a review of the laboratory documentation for staff competency, the reports for one of the four medical assistants was missing. 3. The findings were discussed with the LP, and verified that the 2020 records were absent for one staff member -- 2 of 2 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual under, Individual Quality Control Plan IQCP "Risk Management", patients test reports (EMR) and interview with the laboratory personnel, it was determined that from 12/18/2017 to 06 /04/2019 for 1 out of 10 patients' test reports records reviewed, the laboratory failed to establish and follow written policies and procedures for proper recording of patient specimen information. The Findings included: a. Review of the "Affirm Patient Test Log" for Trichomonas vaginalis (T), Gardnerella vaginalis (G) and Candida vaginalis (C) testing performed on 04/03/2018 for patient MRN 11601421 showed that the patient's Trichomonas vaginalis result on the Afform patient test log did not match the patient's result found in the patient's electronic final report (EMR). Date PT ID Results* T G C 04/03/2018 116021421 (+) (-) (-) * (+) = Pos, (-) - Neg The laboratory's IQCP under "Rick Management line item 6." state: Patient results not documented in Epic a. Identification in Epic in Provider notes that testing done, but results not documented. b. Test results accurate. c. Results could be communicated verbally to Provider and treatment followed. Results could be looked up in Affirm log and added to Epic record. b. On 10/07/2019 11:30 AM (survey date), the laboratory personnel confirmed showed that the patient's Trichomonas vaginalis result on the Afform patient test log did not match the patient's result found in the patient's electronic final report (EMR). c. Based on the laboratory's annual test volume declaration (07/19/2019) the laboratory performed 131 (Parasitology) tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --